FDA Inspection
Chartwell Pharmaceuticals Carmel LLCChartwell Pharmaceuticals Carmel LLC – FDA Inspection, Dec 20, 2024
Record Details
This FDA Inspection record concerns Chartwell Pharmaceuticals Carmel LLC, with an inspection on December 20, 2024, issued by the New York District Office, covering human drugs.
View Company Profile
ID · ccea6d9e-15b4-4ccd-98f6-aa48def54a9a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1257461
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
FDA Citations
3- 21 CFR 211.176Failing to test for penicillin cross-contamination
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Chartwell Pharmaceuticals Carmel LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2024 | OAI | New York District Office | Generic Drug Evaluation |
| October 6, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 28, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 2, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Chartwell Pharmaceuticals Carmel LLC
- FDA Inspection 1227007 - 2024-01-11
- FDA Inspection 1181090 - 2022-10-06
- FDA Inspection 1112833 - 2019-12-16
- FDA Inspection 1043109 - 2018-02-28
- FDA Inspection 947416 - 2015-11-02
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.